FDA Requires Additional Testing Of Heartburn Medications

By Kelly Lienhard / December 5, 2019 at 2:27 PM
FDA announced Thursday (Dec. 5) that it will require companies that make heartburn medications to expand testing for the carcinogenic impurity N-nitrosodimethylamine (NDMA). The testing is focused on nizatidine and ranitidine-based drugs, like Zantac. FDA says if manufacturer testing shows levels of NDMA that are above the acceptable intake of 96 nanograms a day, then manufacturers must inform FDA and discontinue distributing the medication. FDA was first notified of the NDMA impurity found in ranitidine drugs in September. Shortly after,...

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